FDA Clearance for NxStage System One

NxStage Medical Inc. officials announce that the U.S. Food and Drug Administration (FDA) has cleared new high flow capabilities with the NxStage System One, the only truly portable hemodialysis system cleared for home use. With this clearance, the company expects to begin offering its System One with new higher flow capabilities in the United States later this year.

The new higher flow capabilities for the System One enable increased dialysate flow rates, allowing nephrologists expanded possibilities to adjust the duration and frequency of patient prescriptions. Patients can now enjoy the benefits of home hemodialysis and have even greater treatment flexibility based on their clinical and lifestyle needs.

"This latest regulatory milestone reflects strong and systematic execution against our product pipeline," states Jeffrey Burbank, CEO, NxStage Medical, Inc. "With this new capability, NxStage therapy may be prescribed less frequently, for example three times per week or every other day, at treatment times consistent with those that patients and physicians experience in-center today. We are strong believers in longer and more frequent dialysis for the clinical benefits; still, high flow opens the NxStage solution more broadly to the patient segment that wants the benefits of home, but at in-center frequency."

NxStage's high flow capabilities also received CE mark approval in February 2013.